NJ Company Sold Illegal Skin-Whitening Drugs Made With Human Afterbirth
ASBURY PARK — A Monmouth County company is being forced to recall and destroy numerous injectable skin drugs that federal officials say were illegally manufactured and contain human placenta that could expose users to HIV, hepatitis and herpes infections.
The owners of Flawless Beauty and RDG Imports, with offices in this city and Ocean Township, agreed to settle the case brought by the Department of Justice on behalf of the Food and Drug Administration.
The permanent injunction is the latest action that federal regulators have taken against majority owner Jack H. Gindi, whose Flawless Beauty operation was forced to recall injectable products in 2014 and had $10,000 worth of confiscated drugs destroyed by U.S. Marshals in 2015.
Susana B. Boleche, a minority owner and "the face" of the company, was also part of the federal court action.
In the latest inspections, authorities found that the companies were importing and selling unapproved and misbranded drugs in violation of the federal Food, Drug and Cosmetic Act.
The feds say the drugs posed serious health risks because they have not been properly vetted or sold with appropriate instructions.
The complaint against the companies says products containing human placenta — which is the organ that helps nourish a fetus — can cause serious viral infections.
The feds also said that the companies' 500 products were promoted with dubious claims, including unsubstantiated assertions that the beauty products helped liver and lung function, cured Parkinson's disease and lowered cholesterol and blood pressure.
The products included labels that wrongly suggested they had been approved by the FDA.
Under the law, for a drug to be considered safe and effective, its maker has to provide "substantial evidence of safety and effectiveness" demonstrated through clinical trials and studies published in scientific, peer-reviewed literature.
The federal court injunction bars the companies from distributing unapproved and misbranded drugs. The recall and destruction of the illegal injectable drugs will be done under FDA supervision, officials said Tuesday.
The drugs were being sold on FlawlessBeautyandSkin.com and Relumins.com and were promoted on a Facebook page with more than a million followers.
Authorities say the companies imported the drugs from the Philippines, New Zealand, China and Japan, and shipped them to buyers New Jersey, Texas, Florida, California and Maryland. Skin-whitening products are a fad in some Asian nations.
Among the products cited by the feds:
- Relumins Advanced Glutathione and New Relumins Advanced Glutathione 3500 mg
- Tatiomax Glutathione Collagen Whitening
- Laennec Human Placenta Whitening
- Relumins Advanced Oral Whitening & Antiaging Stack
- Authentic Relumins Advanced White Stem Cell Therapy All In One Day Lotion
- Authentic Relumins Advance Whitening Facial Cream With TA Stem Cell & Placenta
- Relumins Medicated Professional Acne & Dark Spot Fighting Set
- Natural Pearl Whitening Lotion; Authentic Kustie Beauty Slimming Activated Hot
- Authentic Mosbeau Placenta White Clarifying Toner
- Gluta PowerPeel Soap; Relumins Advance White-Whitening Deodorant Roll-On
- Sante Barley Fusion
The FDA went after Gindi in 2013 when it informed him that his import company's products had been rejected because the drugs had not been approved by the FDA. His company had been called Xceed College Advisors until he changed it to Flawless Beauty in 2012.
In 2015, Gindi told FDA inspectors that he was no longer importing illegal drugs, the court complaint says.